A move by the Food and Drug Administration toward making the morning-after pill available over the counter could damage women's health and put more pressure on pharmacists conscientiously opposed to dispensing the drug, according to the U.S. bishops' pro-life spokeswoman.

The FDA announced July 31 that it would work with Duramed, a subsidiary of Barr Pharmaceuticals that manufactures the drug marketed as Plan B, to develop a "framework for moving emergency contraception medication to over-the-counter status" for women 18 and older.

Deirdre McQuade, director of planning and information for the bishops' Secretariat for Pro-Life Activities, criticized the FDA's decision in a July 31 statement.

Plan B uses large doses of birth-control pills to prevent conception up to 72 hours after unprotected sex. "But even its proponents admit that it works both before and after conception," McQuade said, adding that many women are "unaware of (the pills') abortifacient action."

"Making this powerful, abortifacient drug available without a doctor's oversight could place women and their newly conceived children at risk," she said. "Women for whom the drug is dangerous would not have the benefit of any clinical advice to alert them to the risks."

McQuade also said FDA approval of over-the-counter sales would "place additional pressure on pharmacists who conscientiously object to dispensing drugs that kill humans at their earliest stages of development."

Barr Pharmaceuticals originally had sought approval for over-the-counter sales of Plan B to anyone 16 or over. Then-FDA Commissioner Lester M. Crawford announced in August 2005 that the agency would not grant such approval and set a 60-day period for comment. Crawford resigned his post that October.

Dr. Andrew von Eschenbach, acting FDA commissioner, said in a July 31 letter to Duramed that the agency had received approximately 47,000 comments, and "we concur with the overwhelming majority of the comments ... that it is not necessary to engage in rulemaking to resolve the novel regulatory issues raised by your application."

In a comment on behalf of the U.S. Conference of Catholic Bishops, Mark Chopko, USCCB general counsel, said over-the-counter sales of Plan B "would be injurious to many -- children and adults, as well as health care providers and professionals."

Chopko said any effort to restrict over-the-counter sales of the morning-after pill to those over the age of 16 would be doomed to failure.

"We believe, as we stated in previously filed comments, that permitting the over-the-counter sale of Plan B would be detrimental to minors (and adults) notwithstanding any effort to limit marketing to adults," he wrote.

"As a practical matter," he added, "a minor could procure the drug indirectly through a nonparental adult, or might obtain it directly as a result of lax enforcement by the pharmacy, misrepresentation or theft."

In his letter to Duramed, von Eschenbach said the issues remaining to be resolved in discussions with the pharmaceutical company include the marketing, education, distribution and monitoring of over-the-counter sales of the drug.

Under Duramed's plan, the over-the-counter version of Plan B "would not be available at gas stations, convenience stores, etc., but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy counter and (2) dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer," the FDA official said.

The agency wants to "learn more about your plan to routinely monitor these pharmacies" and is "very interested in learning how you plan on enforcing the restrictions if a pharmacy fails to comply with them," he added.

"If after our discussions we conclude that the (Duramed plan) isn't sufficiently rigorous to prevent the OTC version of Plan B from being used by young girls ..., Plan B will remain prescription-only for women of all ages," von Eschenbach said.

In a news release, the FDA said it hopes the discussion process "can be wrapped up in a matter of weeks."

-- CNS